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湿性敷料联合壳聚糖创面敷料治疗深Ⅱ度烧伤创面的临床疗效:前瞻性、随机、单盲、阳性对照临床试验。

Clinical efficacy of wet dressing combined with chitosan wound dressing in the treatment of deep second-degree burn wounds: A prospective, randomised, single-blind, positive control clinical trial.

机构信息

Department of Burn and Wound Repair, Yueqing City People's Hospital: Wenzhou Medical College Affiliated Yueqing Hospital, Yueqing County, Wenzhou, China.

出版信息

Int Wound J. 2023 Mar;20(3):699-705. doi: 10.1111/iwj.13911. Epub 2022 Aug 3.

Abstract

To evaluate the efficacy and safety of wet dressing combined with chitosan wound dressing for deep II degree burn wounds, and provide the basis for clinical application. From October 2019 to October 2021, 80 patients with second-degree deep burn treated in the Department of burn and plastic surgery of our hospital were selected as the research objects. Patients were randomly divided into two groups. The control group (40n) was treated with wet compress, and the study group (40n) was treated with wet compress combined with chitosan wound dressing. The wound healing time, wound healing percentage and pain score were used as the effectiveness indexes, and the incidence of adverse events and serious adverse events and the detection rate of bacterial culture of wound exudates were used as the safety indexes. The efficacy and safety of the two groups were compared. The wound healing time of the study group (19.53 ± 2.74 days) was shorter than that of the control group (24.78 ± 4.86 days), the difference was significant (t = 3.571, P = 0.015). The percentage of wound healing at the 14th after treatment in the study group was higher than that in the control group (65.00% versus 37.50%) (X  = 6.054, P = 0.014). There was no significant difference in pain scores between the two groups at each time point. The scar growth was observed 3 months after wound healing. The scar score of the study group (6.00 ± 0.98) was lower than that of the control group (8.77 ± 1.19) (t = 2.571, P = 0.031). The positive rate of wound secretion culture on the 7th and 14th day was statistically significant (X  = 4.528, P = 0.033; X  = 6.646, P = 0.010), and the study group was lower than the control group (29.03% versus 81.82%; 8.11% versus 42.86%). There was no significant difference in treatment cost between the study group and the control group (1258.7 ± 223.6 versus 1248.9 ± 182.3) (t = 1.571, P = 0.071). No adverse events or serious adverse events occurred in both groups. Chitosan wound dressing can significantly shorten the time of wound healing and reduce wound pain and wound infection in patients with deep second-degree burns. And it can effectively improve the situation of scar hyperplasia, which is worthy of clinical application.

摘要

为评价湿性敷料联合壳聚糖创面敷料治疗深Ⅱ度烧伤创面的疗效和安全性,为临床应用提供依据。选取 2019 年 10 月—2021 年 10 月在我院烧伤整形科治疗的 80 例深Ⅱ度烧伤患者作为研究对象,将患者随机分为两组,对照组(40 例)采用湿性敷料治疗,观察组(40 例)采用湿性敷料联合壳聚糖创面敷料治疗。以创面愈合时间、创面愈合率及疼痛评分作为疗效指标,以不良反应及严重不良反应发生率、创面分泌物细菌培养检出率作为安全性指标,比较两组患者的疗效及安全性。观察组患者的创面愈合时间(19.53±2.74)d 短于对照组(24.78±4.86)d,差异有统计学意义(t=3.571,P=0.015);观察组患者治疗后第 14 天的创面愈合率为 65.00%,高于对照组的 37.50%(X²=6.054,P=0.014);两组患者各时间点的疼痛评分比较,差异无统计学意义。创面愈合后 3 个月观察瘢痕生长情况,观察组患者的瘢痕评分(6.00±0.98)低于对照组(8.77±1.19)(t=2.571,P=0.031)。观察组患者第 7、14 天的创面分泌物培养阳性率均低于对照组,差异有统计学意义(X²=4.528,P=0.033;X²=6.646,P=0.010),分别为 29.03%、8.11%,对照组为 81.82%、42.86%。观察组与对照组患者的治疗费用比较,差异无统计学意义(1258.7±223.6 比 1248.9±182.3)(t=1.571,P=0.071)。两组患者均未发生不良反应及严重不良反应。壳聚糖创面敷料可明显缩短深Ⅱ度烧伤患者的创面愈合时间,减轻创面疼痛及降低创面感染,有效改善瘢痕增生情况,值得临床应用。

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